Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

Phase II Randomized, Multicenter, Double-blind, Doubledummy, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.

Inclusion Criteria:

• Participants aged between 18 and 64 years;
• Participants diagnosed with insomnia disorder according to the criteria defined by the DSM-V (1) and who report sleep maintenance disorder;
• Participants who agree not to use alcoholic beverages during the entire treatment period (6 weeks).

Exclusion Criteria:

• Participants with known hypersensitivity to the active ingredients used during the trial or who have exhibited complex sleep behavior after using them;
• Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years;
• Women who are pregnant or breastfeeding, as well as women who have a positive result on a pregnancy test (β-hCG) during the screening period of the trial;
• Participants diagnosed with severe liver failure;